A Prospective, Multicenter, Open Label Clinical Study of the Safety andEfficacy of the Avenue L Interbody Spinal Fusion System Using the VerteBRIDGE Plating System and Supplemental Posterior Fixation

LDR Spine USA4 sites in 1 country13 target enrollmentJuly 15, 2013

ConditionsDegenerative Disc Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Degenerative Disc Disease
Sponsor: LDR Spine USA
Enrollment: 13
Locations: 4
Primary Endpoint: Fusion Rate
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this prospective clinical study is to examine the short-term safety and efficacy of the Avenue®- L interbody Spinal Fusion System with VerteBRIDGE® plating to treat one and two level degenerative disc disease between L2 and S1 with a focus on fusion rate.

Registry

clinicaltrials.gov

Start Date

July 15, 2013

End Date

March 23, 2016

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

LDR Spine USA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must be candidates for on-label use of the Avenue L device (have degenerative disc disease, use only at one or two contiguous levels, posterior fixation must be used, autograft must be used in the interbody cage)
•Subject must be skeletally mature at the time of surgery, i.e. the subject must be at least 21 years of age at the time of surgery
•Subject should have had a minimum of 6 months of non-operative treatment prior to surgery
•The placement of the Avenue L device must be a primary surgery
•Subject must be willing to sign the consent form and be able to return for all follow up visits.

Exclusion Criteria

•Subject must not have had prior surgery at the operative level(s)
•Subject is known to have substance or alcohol addictions
•Subject has lateral curvature of the spine (scoliosis, all types)
•Subject is a prisoner
•Subject is pregnant
•Subject has an active infection or sepsis at the time of surgery
•Subject has any neuromuscular disorder that would preclude accurate neurologic evaluations